Phase II study of a combination of S-1 and paclitaxel in patients with unresectable or metastatic gastric cancer

Oncology

Volumn 74, Issue 1-2, 2008, Pages 37-41

  Narahara, Hiroyuki ^a   Fujitani, Kazumasa ^b   Takiuchi, Hiroya ^c   Sugimoto, Naotoshi ^a   Inoue, Kentaro ^d   Uedo, Noriya ^e   Tsukuma, Hideaki ^e   Tsujinaka, Toshimasa ^b   Furukawa, Hiroshi ^f   Taguchi, Tetsuo ^g  

^a HIROSHIMA UNIVERSITY   (Japan)

^b OSAKA NATIONAL HOSPITAL   (Japan)

^c OSAKA MEDICAL COLLEGE HOSPITAL   (Japan)

^d KANSAI MEDICAL UNIVERSITY   (Japan)

^e OSAKA MEDICAL CENTER FOR CANCER AND CARDIOVASCULAR DISEASES   (Japan)

^f SAKAI MUNICIPAL HOSPITAL   (Japan)

^g Osaka Gastrointestinal Cancer Chemotherapy Study Group   (Japan)

Author keywords

Combination chemotherapy; Gastric cancer, unresectable and or metastatic; Paclitaxel; Phase II study; S 1

Indexed keywords

5 CHLORO 2,4 DIHYDROXYPYRIDINE PLUS OXONATE POTASSIUM PLUS TEGAFUR; PACLITAXEL;

ABDOMINAL PAIN; ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; CANCER GROWTH; CANCER SURVIVAL; CANCER THERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG ACTIVITY; DRUG EFFICACY; FATIGUE; FEMALE; HAND FOOT SYNDROME; HOT FLUSH; HUMAN; LEUKOPENIA; MALE; MUCOSA INFLAMMATION; NAUSEA; NEUROPATHY; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SENSORY NEUROPATHY; SIDE EFFECT; STOMACH CANCER; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DRUG COMBINATIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; OXONIC ACID; PACLITAXEL; STOMACH NEOPLASMS; TEGAFUR; TREATMENT OUTCOME;

EID: 46249120738     PISSN: 00302414     EISSN: None     Source Type: Journal    
DOI: 10.1159/000138978     Document Type: Article

References (24)

1. Boku N, Yamamoto S, Shirao K, Doi T, Sawaki A, Koizumi W, Saito H, Yamaguchi K, Kimura A, Ohtsu A: Randomized phase III study of 5-fluorouracil (5-FU) alone versus combination of irinotecan and cisplatin (CP) versus S-1 alone in advanced gastric cancer (JCOG9912). J Clin Oncol 2007;25(suppl 18):200.
2. Narahara H, Koizumi W, Hara T, Takagane A, Akiya T, Takagi M, Miyashita K, Nishizaki T, Kobayashi O: Randomized phase III study of S-1 alone versus S-1 + cisplatin in the treatment for advanced gastric cancer (the SPIRITS trial). SPIRITS: S-1 plus cisplatin vs S-1 in RCT in the treatment for stomach cancer. J Clin Oncol 2007;25(suppl 18):201.
3. Tatsumi K, Fukushima M, Shirasaka T, Fujii S: Inhibitory effects of pyrimidine, barbituric acid and pyridine derivatives on 5-fluorouracil degradation in rat liver extracts. Jpn J Cancer Res 1987;78:748-755.
4. Shirasaka T, Shimamoto Y, Fukushima M: Inhibition by oxonic acid of gastrointestinal toxicity of 5-fluorouracil without loss of its antitumor activity in rats. Cancer Res 1993;53:4004-4009.
5. Shirasaka T, Shimamato Y, Ohshimo H, Yamaguchi M, Kato T, Yonekura K, Fukushima M: Development of a novel form of an oral 5-fluorouracil derivative (S-1) directed to the potentiation of the tumor selective cytotoxicity of 5-fluorouracil by two biochemical modulators. Anticancer Drugs 1996;7:548-557.
6. Shirasaka T, Nakano K, Takechi T, Satake H, Uchida J, Fujioka A, Saito H, Okabe H, Oyama K, Takeda S, Unemi N, Fukushima M: Antitumor activity of 1 M tegafur-0.4 M 5-chloro-2,4-dihydroxypyridine-1 M potassium oxonate (S-1) against human colon carcinoma orthotopically implanted into nude rats. Cancer Res 1996;56:2602-2606.
7. Ohtsu A, Boku N, Tamura F, Muro K, Shimada Y, Saigenji K, Akazawa S, Kitajima M, Kanamaru R, Taguchi T: An early phase II study of a 3-hour infusion of paclitaxel for advanced gastric cancer. Am J Clin Oncol 1998;21:416-419.
8. Ohtsu A, Shirao K, Miyata Y, Hyodo I, Saito H, Taguchi T: A phase II study of three-hour infusion paclitaxel in patients with advanced gastric cancer. Proc ASCO 2000;19:303a.
9. Arai T, Hamaguchi T, Shirao K, Shimada Y, Yamada Y, Muro K, Ura T, Goto A: Weekly paclitaxel (PTX) in patients with heavily treated advanced gastric cancer (AGC). Jpn J Cancer Clin 2003;49:621-625.
10. Ito S, Kodera Y, Mochiki Y, Yamamura Y: Feasibility study of weekly paclitaxel as second-line chemotherapy against 5-FU-refractory gastric carcinoma. Jpn J Cancer Chemother 2005;32:1427-1430.
11. Kodera Y, Ito S, Mochizuki Y, Fujitake S, Koshikawa K, Kanyama Y, Matsui T, Kojima H, Takase T, Ohashi N, Fujiwara M, Sakamoto J, Nakao A, for Chubu Clinical Cancer Group: A phase II study of weekly paclitaxel as second-line chemotherapy for advanced gastric cancer (CCOG0302 Study). Anticancer Res 2007;27:2667-2672.
12. Bokemeyer C, Hartmann JT, Lampe CS, Clemens MR, Quietzsch D, Forkmann L, Kanz L: Paclitaxel and weekly 24-hour infusion of 5-fluorouracil/folinic acid in advanced gastric cancer. Semin Oncol 1997;24:S96-S100.
13. Murad AM, Petroianu A, Guimaraes RC, Aragao BC, Cabral LOM, Scalabrini-Neto AO: Phase II trial of the combination of paclitaxel and 5-fluorouracil in the treatment of advanced gastric cancer. Am J Clin Oncol 1999;22:580-586.
14. Kim YH, Shin SW, Kim BS, Kim JH, Kim JG, Mok YJ, Kim CS, Rhyu HS, Hyun JH, Kim JS: Paclitaxel, 5-fluorouracil, and cisplatin combination chemotherapy for the treatment of advanced gastric carcinoma. Cancer 1999;85:295-301.
15. Kollmannsberger C, Quietzsch D, Haag C, Lingenfelser T, Schroeder M, Hartmann JT, Baronius W, Hempel V, Clemens M, Kanz L, Bokemeyer C: A phase II study of paclitaxel, weekly, 24-hour continuous infusion 5-fluorouracil, folinic acid and cisplatin in patients with advanced gastric cancer. Br J Cancer 2000;83:458-462.
16. Honecker F, Kollmannsberger C, Quietzsch D, Haag C, Schroeder M, Spott C, Hartmann JT, Baronius W, Hempel V, Kanz L, Bokemeyer C: Phase II study of weekly paclitaxel plus 24-h continuous infusion 5-fluorouracil, folinic acid and 3-weekly cisplatin for the treatment of patients with advanced gastric cancer. Anticancer Drugs 2002;13:497-503.
17. Fujitani K, Narahara H, Takiuchi H, Tsujinaka T, Satomi E, Gotoh M, Hirao M, Furukawa H, Taguchi T: Phase I and pharmacokinetic study of S-1 combined with weekly paclitaxel in patients with advanced gastric cancer. Oncology 2005;65:414-420.
18. Mochiki E, Ohno T, Kamiyama Y, Aihara R, Haga N, Ojima H, Nakamura J, Ohsawa H, Nakabayashi T, Takeuchi K, Asao T, Kuwano H: Phase I/II study of S-1 combined with paclitaxel in patients with unresectable and/or recurrent advanced gastric cancer. Br J Cancer 2006;95:1642-1647.
19. Hokita S, Aikou T, Ishigami S, Miyazono F, Nakajo A, Uenosono Y, Hamanoue M, Aridome K, Natsugoe S: Combination chemotherapy study of biweekly paclitaxel and S-1 administration in patients with advanced gastric cancer. Jpn J Chemother 2006;33:95-98.
20. Inokuchi M, Yamashita T, Yamada H, Kojima K, Ichikawa W, Nihei Z, Kawano T, Sugihara K: Phase I/II study of S-1 combined with irinotecan for metastatic advanced gastric cancer. Br J Cancer 2006;94:1130-1135.
21. Koizumi W, Tanabe S, Saigenji K, Ohtsu A, Boku N, Nagashima F, Shirao K, Matsumura Y, Gotoh M: Phase I/II study of S-1 combined with cisplatin in patients with advanced gastric cancer. Br J Cancer 2003;89:2207-2212.
22. Iwase H, Shimada M, Tsuzuki T, Horiuchi Y, Kumada S, Haruta J, Yamaguchi T, Sugihara M, Ina K, Kusugami K, Goto S: A phase II multicentric trial of S-1 combined with 24-h infusion of cisplatin in patients with advanced gastric cancer. Anticancer Res 2005;25:1297-1302.
23. Koizumi W, Kurihara M, Satoh A, Takiuchi H, Tanabe S, Shimada K, Iwasaki R, Saigenji K: Phase I/II study of bi-weekly irinotecan plus cisplatin in the treatment of advanced gastric cancer. Anticancer Res 2005;25:1257-1262.
24. Nukatsuka M, Fujioka A, Nakagawa F, Oshimo H, Kitazato K, Uchida J, Sugimoto Y, Nagayama S, Fukushima M: Antimetastatic and anticancer activity of S-1, a new oral dihydropyrimidine-dehydrogenase-inhibiting fluoropyrimidine, alone and in combination with paclitaxel in an orthotopically implanted human breast cancer model. Int J Oncol 2004;25:1531-1536.